1.
Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY).
Peyrin-Biroulet, L, Loftus, EV, Colombel, JF, Danese, S, Rogers, R, Bornstein, JD, Chen, J, Schreiber, S, Sands, BE, Lirio, RA
Gastroenterology. 2021;(4):1156-1167.e3
Abstract
BACKGROUND AND AIMS VARSITY (An Efficacy and Safety Study of Vedolizumab Intravenous [IV] Compared to Adalimumab Subcutaneous [SC] in Participants With Ulcerative Colitis) showed superior clinical remission and endoscopic improvement in ulcerative colitis with vedolizumab vs adalimumab. This analysis compared histologic outcomes. METHODS Patients in VARSITY were randomized 1:1 to maintenance with vedolizumab IV 300 mg every 8 weeks or adalimumab SC 40 mg every 2 weeks (both following standard induction). Geboes Index and Robarts Histopathology Index (RHI) scores were used to assess prespecified histologic exploratory end points of histologic remission (Geboes <2 or RHI ≤2) and minimal histologic disease activity (Geboes ≤3.1 or RHI ≤4) at weeks 14 and 52. RESULTS In total, 769 patients received vedolizumab (n = 383) or adalimumab (n = 386). Mean baseline histologic disease activity was similar between vedolizumab and adalimumab groups. Vedolizumab induced greater histologic remission than adalimumab at week 14 (Geboes: 16.7% vs 7.3%, Δ9.4% [95% confidence interval {CI}, 4.9%-13.9%], P < .0001; RHI: 25.6% vs 16.1%, Δ9.5% [95% CI, 3.8%-15.2%], P = .0011) and week 52 (Geboes: 29.2% vs 8.3%, Δ20.9% [95% CI, 15.6%-26.2%], P < .0001; RHI: 37.6% vs 19.9%, Δ17.6% [95% CI, 11.3%-23.8%], P < .0001) overall and in both anti-tumor necrosis factor (TNF)-naïve and -failure subgroups. Results were similar for minimal histologic disease activity. Histologic outcomes were generally better in anti-TNF-naïve vs -failure patients. At week 52, rates of mucosal healing (composite end point of histologic plus endoscopic improvement) were also higher with vedolizumab than adalimumab (Geboes: 25.6% vs 6.7%; RHI: 30.5% vs 14.5%). CONCLUSIONS Higher rates of histologic remission, minimal histologic disease activity, and combined histologic plus endoscopic outcomes were observed with vedolizumab than with adalimumab in ulcerative colitis in both anti-TNF-naïve and -failure subgroups. REGISTRATION ClinicalTrials.gov NCT02497469; EudraCT 2015-000939-33.
2.
Randomized clinical trial of Chinese herbal medications to reduce wound complications after mastectomy for breast carcinoma.
Chen, J, Lv, Q, Yu, M, Zhang, X, Gou, J
The British journal of surgery. 2010;(12):1798-804
Abstract
BACKGROUND Ischaemia and necrosis of skin flaps is a common complication after mastectomy. This study evaluated the influence of anisodamine and Salvia miltiorrhiza on wound complications after mastectomy for breast cancer. METHODS Ninety patients undergoing mastectomy for breast carcinoma were divided into three groups. Group 1 received routine wound care, group 2 received intravenous Salvia miltiorrhiza after surgery for 3 days and group 3 similarly received intravenous anisodamine. Skin flaps were observed on postoperative days 4 and 8; areas of wound ischaemia and necrosis were graded and adverse events recorded. RESULTS There was no difference in demographic characteristics between the groups. At 4 days after surgery the rate of ischaemia and necrosis in groups 2 and 3 was significantly reduced compared with that in control group 1 (median wound score 6·80 versus 23·38, P = 0·002, and 3·76 versus 23·38, P < 0·001, respectively). This improvement in groups 2 and 3 continued to postoperative day 8 (both P < 0·001), but wound scores at this stage were better in group 3 than in group 2 (1·82 versus 6·92 respectively; P = 0·022). The volume of wound drainage was lower in group 3 than in group 1 (P = 0·004). The incidence of adverse effects was highest in group 3, and two patients in this group discontinued treatment. No significant complications were noted in group 2. CONCLUSION Anisodamine and S. miltiorrhiza were both effective in reducing skin flap ischaemia and necrosis after mastectomy, although anisodamine was associated with a higher rate of adverse effects.